A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the Blood

A Phase 1, Open-label, Randomized, Crossover, Multiple Dose, Pivotal Bioequivalence Study To Compare Pf-06291826 4 X 20 Mg Tafamidis Meglumine And 61 Mga Tafamidis Free Acid Soft Gelatin Capsules Administered Under Fasted Conditions To Healthy Volunteers

2 different formulations and doses of tafamidis will be compared. All subjects will receive both doses/formulations. Subjects will take tafamidis for 7 days, on the first 2 days they will take tafamidis twice, 12 hours apart and then once a day for the next 5 days. Subjects will be fasted before taking the drug. Blood samples will be taken to measure the amount of tafamidis starting on day 7 and ending on day 8. At least 16 days after the first formulation/dose is given, all subjects will repeat the procedure with the other formulation/dose.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: tafamidis

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, B-1070
    • Pfizer Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy males of females of non-childbearing potential
• Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)

Exclusion Criteria:

• Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).
• Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer)
• Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 61 mgA tafamidis free acid soft gelatin capsule	Drug: tafamidis; bioequivalence study
Experimental: 4x20 mg tafamidis meglumine soft gelatin capsule	Drug: tafamidis; bioequivalence study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve (AUC)	24 hours
maximum observed plasma concentration (Cmax)	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
minimum observed plasma concentration (Cmin)	24 hours
Time to maximum observed plasma concentration (Tmax)	24 hours

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2017
• Primary Completion (Actual): February 15, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Actual): May 14, 2018
• Last Update Submitted That Met QC Criteria: May 11, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: B3461056; 2017-002572-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes